Join us on September 28 for a Webinar on Washington’s My Health My Data Act and other Consumer Health Data Regulation

By Squire Patton Boggs on September 20, 2023 Posted in Data Protection, Digital Health

With its private right of action and expansive scope – extending far beyond Washington state’s borders and applying to a wide swath of health- and non-health-oriented companies alike – Washington’s My Health My Data Act is poised to be more ground-shifting than any other consumer privacy law that came before it. Join Kyle Fath, Bola Shonowo and Gicel Tomimbang for a discussion of:

What is “consumer health data” and who is a “consumer” under the law?
Key obligations, including privacy policy requirements, consumer rights, and required consents and authorizations for collection, “sharing” and “selling”
Jurisdictional scope, litigation and enforcement details
Other legislative and regulatory schemes that are filling the gap left by HIPAA, including health data-specific state privacy laws in Connecticut and Nevada, general state consumer privacy laws, such as the California Consumer Privacy Act (CCPA) and the Colorado Privacy Act (CPA), and the FTC’s Health Breach Notification Rule

Date: Thursday, September 28 at 12 ET

Register for free here.

Congressional Republicans Solicit Comments from Health Stakeholders

By Beth Goldstein on September 12, 2023 Posted in Legislation, Policy

Over the past several weeks, Congressional Republicans have indicated they are gearing up to tackle various health policy issues – and have offered health stakeholders the opportunity to provide feedback and their expertise in policy development.

On August 25, Republicans on the House of Representatives’ Committee on the Budget established a “Health Care Task Force.” Chaired by Rep. Michael Burgess, MD (R-TX), the Task Force is charged with “find[ing] solutions to reduce health care spending, examin[ing] opportunities to modernize and personalize the health care system, and support[ing] policies to fuel innovation and increase patient access to quality and affordable care.” The Task Force released an open letter, requesting: (1) feedback on regulatory, statutory, or implementation barriers that could be addressed to reduce health care spending; (2) information on efforts to promote and incorporate innovation into programs like Medicare to reduce health care spending and improve patient outcomes; (3) comments on the Congressional Budget Office’s modeling capabilities on health care policies, including limitations or improvements to such analyses and processes; (4) examples of evidence-based, cost-effective preventive health measures or interventions that can reduce long term health costs; and (5) recommendations to reduce improper payments in federal health care programs. Responses are due October 15, 2023.

The Impact of India’s New Privacy Law on Healthcare

By Charmian Aw and Bindu Janardhanan on August 29, 2023 Posted in Cybersecurity, Data Protection, India

In August 2023, India’s Digital Personal Data Protection Act (Act) received presidential assent, formalizing its first ever comprehensive and union-wide data protection law. The Act differs in many respects from a preceding version that was withdrawn in 2022, and reflects intensive discussion and revisions since then. In its final form, the Act reflects the central government’s concerns to preserve and enhance a pro-business and pro-innovation environment for the country.

Summer Roundup: Antitrust Agencies Continue Scrutiny of Healthcare Markets and Attain Much Needed Victories

By Kaitlin Rittgers and Christopher Gordon on August 24, 2023 Posted in Accountable Care Organizations, Antitrust, DOJ, FTC, Mergers and Acquisitions, Pharmaceutical

This summer, the Federal Trade Commission (“FTC”) and U.S. Department of Justice (“DOJ”) (together “antitrust agencies” or “agencies”) continued to push boundaries on what constitutes anticompetitive conduct with the withdrawal of key healthcare policy statements and heightened scrutiny of the pharmaceutical industry. This summer also saw the DOJ and FTC score crucial enforcement wins in the form of two major healthcare settlements. Anticompetitive conduct in healthcare markets has been a top priority for the Biden Administration (see Biden’s July 2021 Executive Order on Promoting Competition in the American Economy). Scrutiny of the markets, therefore, is expected. Companies are advised, however, to keep apprised of recent enforcement actions as the antitrust agencies continue to break ground in new ways. We outline below four recent agency actions that have important antitrust implications for how companies operating in healthcare markets should act moving forward.

Group of Bipartisan Senators Inquire Into the Oversight of Nonprofit Hospitals’ Tax-Exempt Requirements and Compliance

By Beth Goldstein on August 22, 2023 Posted in Community Benefit, Hospitals, Nonprofits, Policy, Tax

Demonstrating that hospital finances and billing practices continue to be of interest to federal lawmakers, on August 7, a group of bipartisan senators sent letters to the Internal Revenue Service (IRS) and the Treasury Inspector General for Tax Administration (TIGTA) questioning the oversight of nonprofit hospitals. Sens. Elizabeth Warren (D-MA), Chuck Grassley (R-IA), Raphael Warnock (D-GA), and Bill Cassidy (R-LA) requested an evaluation of these hospitals’ compliance with tax-exempt requirements, noting they “are alarmed by reports that despite their tax-exempt status, certain nonprofit hospitals may be taking advantage of this overly broad definition of ‘community benefit’ and engaging in practices that are not in the best interest of the patient. These practices – along with lax federal oversight – have allowed some nonprofit hospitals to avoid providing essential care in the community for those who need it most.”

The Departments of Labor, Health and Human Services, and the Treasury Issue Notice of Proposed Rulemaking Related to the Mental Health Parity and Addiction Equity Act

By Ima Nsien and Kristine Woliver on August 7, 2023 Posted in HHS, Insurance, Labor and Employment, Proposed Rule

On July 25, 2023, the Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) proposed rules designed to strengthen the Mental Health Parity and Addiction Equity Act’s (“MHPAEA”) goal of ensuring people seeking treatment for mental health and substance use disorders (“MH/SUD”) face no greater barriers to accessing care than those seeking treatment for medical and surgical (“M/S”) conditions.

New Medicare Marketing Definition

By Doug Anderson on July 27, 2023 Posted in CMS, Insurance, Medicare Advantage

On May 10, 2023, the Center for Medicare & Medicare Services (“CMS”) issued guidance to clarify the definition of “marketing” for Medicare Advantage Plans (“MA Plans”) and Prescription Drug Plans (“PDPs”).[1] The new definition expands “marketing” to include activities intended to draw a consumer’s attention to an MA Plan or PDP, influence a consumer’s decision-making process, or influence a consumer’s decision to stay enrolled in an MA Plan or PDP. This new definition of marketing takes effect on July 10, 2023.

Supreme Court Holds Some Provisions of Federal Nursing Home Reform Act are Privately Enforceable under 42 U.S.C. §1983

By Robert Nauman on July 26, 2023 Posted in U.S. Supreme Court

Last month, the U.S. Supreme Court issued its decision in Health and Hospital Corporation of Marion County v. Talevski, holding that certain provisions of the Federal Nursing Home Reform Act (FNHRA) confer rights that are enforceable by individuals under 42 U.S.C. §1983. The case arises over HHC’s alleged treatment of a resident, Gorgi Talevski. Mr. Talevski’s family filed suit against HHC claiming that HHC’s treatment of Mr. Talevski violated certain rights guaranteed to him under the FNHRA, specifically the right to be free from unnecessary chemical restraints and certain discharge rights. The question before the Court was whether these FNHRA provisions conferred individual rights which may be privately enforced under §1983, or whether the fact that the FNHRA was enacted pursuant to Congress’s spending power precluded such action.

Florida Electronic Health Records Exchange Act Amended – Health Records Maintained by Qualifying Health Care Providers Must Be Stored in the U.S., U.S. Territories, and Canada Only

By Julia Jacobson, John Wyand, Kimberly Donovan and Gicel Tomimbang on June 20, 2023 Posted in Data Protection, Digital Health, Electronic Health Records, Florida, HIPAA

On May 8, 2023, Governor Ron DeSantis of Florida signed CS/CS/SB 264, amending a suite of Florida statutes to impose heightened requirements on business activities involving foreign interests. As related to the health care industry, CS/CS/SB 264 amended the Florida Electronic Health Records Exchange Act (“Act”) to, among other things, require “health care providers” that utilize “certified health record technology” to manage health records in an electronic interoperable and digital format to ensure that in addition to maintaining such records in accordance with the requirements of the Health Insurance Portability and Accountability Act (“HIPAA”), the health records must be stored only in environments physically maintained in the U.S., its territories or Canada, effective July 1, 2023. CS/CS/SB 264 also amended Florida licensure requirements for qualifying health care providers, obligating licensees to comply with the amended requirements of the Act, particularly as related to the security and storage of personal medical information outside of U.S. and Canadian jurisdictions, in order to obtain and maintain a license in Florida.

Antitrust Agencies Target Pharmaceutical Mergers in Enforcers Workshop and Lawsuit

By Christopher Gordon and Kaitlin Rittgers on June 19, 2023 Posted in Antitrust, Pharmaceutical

Last month the Federal Trade Commission (“FTC”) sued to block the $27.8 billion acquisition of Horizon Therapeutics plc (“Horizon”) by the biopharmaceutical corporation, Amgen Inc. (“Amgen”). The lawsuit was the latest move by the Biden Administration to tackle the high price of prescription drugs, which President Joe Biden described as “excessive” in his July 2021 Executive Order on Promoting Competition in the American Economy. Notably, this is the first FTC pharmaceutical merger challenge in over a decade. According to FTC Bureau of Competition Director Holly Vedova, the challenge is meant to send “a clear signal to the market: The FTC won’t hesitate to challenge mergers that enable pharmaceutical conglomerates to entrench their monopolies at the expense of consumers and fair competition.”